MalfunctionFTC
LED COLOR LIGHT MASK / APHRONA BEAUTY
Received Jun 23, 2020 · Event occurred Jun 16, 2020
Report MW5095176 · MDR key 10189254
Device
Generic name
Light, Ultraviolet, Dermatological
Manufacturer
Daman Beauty LlcProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Headache
- Headache
Narrative
Description of Event or Problem
BOUGHT AN APHRONA BRAND LED FACE MASK FOR HOME USE BECAUSE IT ADVERTISED THAT IS FDA APPROVED, CAN NOT FIND ANY INFORMATION THAT THIS IS TRUE. HAVING SOME HEADACHES SINCE STARTING HOME TREATMENT, I HAVE STOPPED USE OF THE DEVICE FOR MEANTIME AND WILL SEE MY PHYSICIAN. FDA SAFETY REPORT ID # (B)(4).